FDA EIR - SupraNaturals, LLC - August 16, 2019

An FDA surveillance Good Manufacturing Practice (GMP) inspection of SupraNaturals LLC, a dietary supplement contract manufacturer located in Springville, UT, was conducted from August 12 to August 16, 2019. This inspection, carried out under compliance program 7321.008 for Dietary Supplements, revealed significant deficiencies, some of which were recurring issues from a previous 2016 inspection. The agency issued a 7-item FDA 483, Inspectional Observations, highlighting core violations of 21 CFR Part 111 (GMP for Dietary Supplements). Key issues included the firm's failure to adequately investigate unanticipated deviations from established product specifications, a lack of established component specifications for strength and contamination limits, and insufficient documentation to support in-process specifications. Additionally, the inspection noted that laboratory methods were not verified for intended use, and proper controls for electronic software and paper records were absent. Verbal observations also emphasized the firm's responsibility for specification appropriateness, even when customer-provided, and clarified that cannabidiol (CBD) cannot be used as a dietary ingredient. SupraNaturals LLC management was informed of their responsibility to ensure GMP compliance, with potential regulatory actions ranging from warning letters to injunctions for non-compliance. The company committed to addressing all observations and providing a written response within 15 business days.